The present invention relates to the field of disinfection or sterilization of medical, pharmaceutical, dental, or mortuary devices, and the like. It finds particular application in conjunction with a cartridge holder for a disinfectant or sterilant concentrate for use in the cleaning and disinfecting of flexible endoscopes, and will be described with particular reference thereto. It should be appreciated, however, that the invention is also applicable to the treatment of other devices.
Fluid microbial decontamination systems are typically designed to cause microbes on the item to be removed or killed by a fluid anti-microbial agent. This is achieved in a variety of ways, including bath of anti-microbial liquid, spraying the item with anti-microbial liquid, surrounding the item with anti-microbial vapor, and the like.
Liquid microbial decontamination systems are now widely used for equipment which could not withstand the high temperatures of steam sterilization. Commonly, a technician mixes a liquid disinfectant or sterilant composition, such as peracetic acid or other strong oxidant, and manually immerses the items to be microbially decontaminated in the composition. The high degree of manual labor introduces numerous uncontrolled and unreported variables into the process. There are quality assurance problems with technician errors in the mixing of sterilants, control of immersion times, rinsing of residue, exposure to the ambient atmosphere after the rinsing step, and the like.
To deliver reproducible amounts of sterilants to the microbial decontamination system, a number of packaging systems have been developed. One problem to overcome is that cleaning agents, such as detergents, and pretreatment agents, such as buffers and corrosion inhibitors, tend to degrade peracetic acid. Combining them with liquid peracetic acid results in a reduced shelf life. Thus, for peracetic sterilants, in particular, such components of a treatment system are generally kept separate to prolong shelf life. U.S. Pat. No. 5,037,623 to Schneider, et al., for example, discloses a cup which contains a measured dose of a liquid peracetic acid concentrate. Buffers, detergents, and anticorrosive agents, in the form of a powder, are separately contained. The cup includes a linear vent passage which extends into the interior of the cup. A gas permeable membrane is mounted over the interior end of the vent passage to allow venting of the container during storage.
U.S. Pat. No. 5,662,866 to Siegel, et al. discloses a two-compartment cup for powdered sterilant reagent components. An outer compartment holds a first reagent while an inner compartment, disposed within the outer compartment, holds a second reagent. The two reagents react in water to form an oxidant, such as peracetic acid. Pretreatment agents, such as surfactants, corrosion inhibitors, and sequestering agents, are often included in one of the two compartments. Peripheral walls of inner and outer cups are affixed together at flanges adjacent their open ends to define the two compartments. A permeable sheet is affixed to the inner cup flange for ventedly sealing both cups. The outer cup is closed at its base by a first detachable base and the inner cup is similarly closed by a second detachable base.
To release the sterilant into the fluid flow path of a microbial decontamination system, the cup is inserted into a well in fluid communication with the system. In the case of the liquid sterilant cup, a peel-off top is removed to provide access to the contents of the cup. Alternatively, a cutter, such as that disclosed in U.S. Pat. No. 5,439,654 to Kochte, pierces the base of the cup with a blade. In the case of the powdered sterilant cup with a removable base, pressure is applied to detach the bases of the inner and outer cup portions. Minerovic, et al., U.S. Pat. Nos. 5,997,814 and 6,325,968, discloses two compartment cups in which parts of the cup are formed from a permeable material, allowing the contents of the cup to pass through when dissolved in water. A jet stream of water is sprayed into the cup to dissolve and flush the sterilizing agents from the cup.
In general, the water enters the top of the well, flows through the cup, and passes out of the well though an opening in the bottom. The walls of the well adjacent the sides of the cup, receive reduced contact with the sterilant or disinfectant. In cases where the devices being sterilized or disinfected are heavily contaminated with blood and other biological materials, biofilm may build up on the walls of the well. The biofilm could support microbes during periods of non-use. Rinse water passing through the well may occasionally pick up a portion of this biofilm, leading to recontamination of the devices.
The present invention provides for a new and improved cartridge holder for holding a multi-compartment cup, which overcomes the above-referenced problems and others.